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Table of contents

  1. Front Matter
    Pages 1-24
  2. Part 1 Safety Pharmacology

    1. Front Matter
      Pages 1-1
    2. Franz J. Hock
      Pages 3-4
    3. Vincent Castagné, Christelle Froger-Colléaux, Elise Esneault, Hernier Anne Marie, Martine Lemaire, Roger D. Porsolt
      Pages 17-72
    4. Pascal Champeroux, Brian D. Guth, Michael Markert, Georg Rast
      Pages 73-97
    5. Susan G. Emeigh Hart
      Pages 99-184
    6. Andreas W. Herling
      Pages 199-255
    7. H. Gerhard Vogel
      Pages 257-275
    8. Lars Arendt-Nielsen
      Pages 277-285
    9. Charles P. France
      Pages 287-310
    10. Shaker A. Mousa
      Pages 311-391
    11. Beat P. Mertz
      Pages 393-400
    12. Lars Arendt-Nielsen
      Pages 401-419
    13. Jürgen Sandow
      Pages 421-520
    14. Thais H. Sakuma, Hongbo Zhai, Howard Maibach
      Pages 521-554
    15. Hamid R. Amouzadeh, Hugo M. Vargas
      Pages 555-560
    16. Jason H. Gill
      Pages 573-593
    17. Will S. Redfern, Jean-Pierre Valentin
      Pages 595-603
    18. Björn Lemmer, Maxim Soloviev
      Pages 631-676
    19. A. Michael Bloh
      Pages 691-725
    20. Thomas Rücker
      Pages 727-731
    21. S. W. Mittelstadt
      Pages 733-740
  3. Part 2 Pharmacokinetics

    1. Front Matter
      Pages 741-741
    2. Jochen Maas
      Pages 743-743
    3. Katharina Mertsch
      Pages 745-777
    4. Markus Kohlmann
      Pages 779-797
    5. Volker Krone
      Pages 799-834
    6. Dietmar Schmidt
      Pages 835-852
    7. Joern Krause, Ronald Schmidt
      Pages 853-867
    8. Heinz Jürgen Skrzipczyk, Patrick Verdier
      Pages 869-886
    9. Karl-Heinz Lehr
      Pages 887-896
    10. Andreas W. Herling
      Pages 915-921
    11. Tanja Eisenblaetter, Yohannes Hagos, Saskia Flörl, Annett Kühne
      Pages 923-957
    12. Manfred Zimmer
      Pages 959-968
    13. Yves Archimbaud
      Pages 969-973
    14. Peter Bünning
      Pages 975-987
    15. Angela Dudda, Gert Ulrich Kuerzel
      Pages 989-1004
    16. Hans Matter, Wolfgang Schmider
      Pages 1005-1052
    17. Angela Dudda, Gert Ulrich Kuerzel
      Pages 1053-1094
    18. Jochen Maas, Roland Wesch, Dietmar Weitz
      Pages 1095-1123
    19. Heiko Tietgen, Michael Walden
      Pages 1125-1138
    20. Axel Steinstraesser, Roland Wesch, Annke Frick
      Pages 1139-1210
    21. Willi Weber, Diether Rüppel
      Pages 1211-1218

About this book

Introduction

Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound. These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming of a suitable half-life time and at oral activity. Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function. Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trails. But the success rate in the pharmaceutical industry and the introduction of new chemical entities to the market per year dropped dramatically, whereas the development time for a new compound increased, sometimes exceeding the patent protection. A change of strategy was therefore adopted, involving the following changes:

-          Parallel instead of sequential involvement of the various disciplines (multidimensional compound optimization).

-          The term "Safety Pharmacology" was coined. The International Conference on Harmonization (ICH) founded a Safety Pharmacology Working Group. Easily accessible and the most informative tests now have to be selected.

-          Exposure of a drug to the body by pharmacokinetic studies on absorption, distribution, metabolism and excretion has to be investigated at an early stage of development and can contribute to the selection of a compound for development.

Toxicology experienced major achievements by the introduction of new methods, e.g., in silico methods, toxicogenomics and toxicoproteomics.

The book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.

The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.

In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.

Keywords

Bioanalytical Assays Clinical Studies Safety Assays Safety Pharmacokinetics Safety Pharmacology Safety Toxicology

Editors and affiliations

  • H. Gerhard Vogel
  • Jochen Maas
    • 1
  • Franz J. Hock
    • 2
  • Dieter Mayer
    • 3
  1. 1.Sanofi Pharma Deutschland GmbHA company of the Sanofi-Aventis Group Industriepark HoechstFrankfurt am MainGermany
  2. 2.DieburgGermany
  3. 3.IdsteinGermany

Bibliographic information

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